Study of the Effect of SR57667B on 18F-Dopa PET Imaging in Patients With Parkinson's Disease

This study has been completed.

Sponsor:

Sanofi

ClinicalTrials.gov Identifier:

NCT00220272

First Posted: September 22, 2005

Last Update Posted: December 23, 2008

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The primary objective is to study the effect of SR57667B at the dose of 4 mg/d on progression of dopaminergic nigro-striatal lesions assessed by 18F-Dopa PET imaging.

Secondary objectives are to assess the effect of SR57667B on symptomatic decline in patients with early PD, to assess the safety/tolerability of SR57667B in patients with early PD and to document plasma concentrations of SR57667 in patients with early PD.

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Ages Eligible for Study:

35 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Male or female outpatients.

Age >=35 years at screening.

Diagnosis of Parkinson's syndrome, on at least two of the three key Parkinson's symptoms, i.e. resting tremor, bradykinesia and rigidity.

Duration of the disease of less than 3 years since diagnosis.

Modified Hoehn and Yahr stage <= 2.5.

Patient optimized on monotherapy by levodopa or a dopamine agonist·

Generally healthy and ambulatory.

Patient has given his informed written consent and is capable of following study procedures.

Exclusion Criteria:

Any indication of forms of parkinsonism other than PD.

Severe resting tremor. Presence of either dyskinesia, fluctuations, or loss of postural reflexes·

Dementia, uncontrolled depression, psychotic disorder. History of substance-related disorders including alcohol or other substance use disorders.

Females of child bearing potential.

Evidence (detected by history, physical examination and/or laboratory/ECG tests) of any clinically significant or unstable medical disorder that could interfere with the patient's participation in the clinical trial; interfere with the absorption, metabolism or excretion of the study medication; or interfere with the evaluation of the study drug. Alterations of laboratory tests or ECG findings of potential clinical significance.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00220272